IEC 60601-2-8-2010 Medical electrical equipment - Part 2-8 Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment.pdf

1、 IEC 60601-2-8 Edition 2.0 2010-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV Appareils lectromdicaux Partie 2-8: Exigenc

2、es particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de thrapie fonctionnant dans la gamme de 10 kV 1 MV IEC 60601-2-8:2010 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified,

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17、NAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV Appareils lectromdicaux Partie 2-8: Exigences particulires pour la scurit de base et les

18、 performances essentielles des quipements rayonnement X de thrapie fonctionnant dans la gamme de 10 kV 1 MV INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE W ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-88912-238-7 Registered trademark of the International Elect

19、rotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-8 IEC:2010 CONTENTS FORE WORD 3 INTRODUCTION 5 201.1 Scope, object and related standards 6 201.2 Normative references . 7 201.3 Terms and definitions . 8 201.4 General requirements . 8 201.5 General requir

20、ements for testing of ME EQUIPMENT . 9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 M E EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 15 2

21、01.10 Protection against unwanted and excessive radiation HAZARDS . 15 201.11 Protection against excessive temperatures and other HAZARDS . 30 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 30 201.13 HAZARDOUS SITUATIONS and fault conditions 30 201.14 PROGRAMM

22、ABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 31 201.15 Construction of ME EQUIPMENT . 31 201.16 ME SYSTEMS 31 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31 Bibliography . 32 Index of defined terms used in this particular standard . 33 Table 201.101 Data required in the technical

23、 description to support Clause 201.10 SITE and TYPE TEST compliance 10 Table 201.102 Permissible LEAKAGE RADIATION 16 Table 201.103 Permissible LEAKAGE RADIATION from X-RAY TUBE ASSEMBLIES with BEAM LIMITING DEVICES . 18 Table 201.104 Overview of measurements . 29 60601-2-8 IEC:2010 3 INTERNATIONAL

24、ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization

25、for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publ

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27、participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreeme

28、nt between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Pub

29、lications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or

30、 for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corres

31、ponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for a

32、ny services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and

33、IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Att

34、ention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights.

35、IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60601-2-8 has been prepared by IEC subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practi

36、ce. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards. 4 60601-2-8 IEC:2010 The text of this particular standard is based on

37、the following documents: FDIS Report on voting 62C/499/FDIS 62C/505/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

38、In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. T ERMS DEFI

39、NED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subcla

40、uses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard ar

41、e by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard

42、 the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible

43、way to achieve compliance with a requirement or test. A list of all parts of the IEC 60601 series, published under the general title MEDICAL ELECTRICAL EQUIPMENT, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stabilit

44、y date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 60601-2-8 IEC:2010 5 INTRODUCTION X-RAY EQUIPMENT for RADIOTHERAPY purposes is

45、used for TELETHERAPY, where the RADIATION SOURCE is far from the tissues to the treated (usually more than 50 cm), and also for BRACHYTHERAPY, where the RADIATION SOURCE is positioned within or adjacent to the tissue to be treated. This particular standard covers X-RAY EQUIPMENT for both TELETHERAPY

46、 and BRACHYTHERAPY. The use of X-RAY EQUIPMENT for RADIOTHERAPY purposes may expose the PATIENT to danger if the equipment fails to deliver the required dose to the PATIENT, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger

47、 to persons in the vicinity if the equipment itself fails to contain the radiation adequately and/or if there are inadequacies in the design of the TREATMENT ROOM. This particular standard establishes requirements to be complied with by the MANUFACTURERS in the design and construction of therapeutic

48、 X-RAY EQUIPMENT. Subclause 201.10.1 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to avoid an unsafe condition. Subclause 201.10.1 does not attempt to define optimum performance requirements. Its purpose is to identify those features of design that are

49、 regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists, e.g. a component failure, and where an INTERLOCK then operates to prevent continued operation of the equipment. It should be understood that, before installation, a MANUFACTURER can provide a comp